LLM Information

REGENXBIO Inc.

✓ Verified Manufacturer
Pharmaceuticals 📍 Rockville, MD Est. 2008

About

REGENXBIO Inc stands as a leading clinical-stage biotechnology company headquartered in Rockville, Maryland, specializing in the development and manufacturing of innovative gene therapies using adeno-associated virus vectors. The company operates state-of-the-art manufacturing facilities designed to produce high-quality viral vector products for treating rare diseases and genetic disorders. The organization maintains comprehensive capabilities in vector design, process development, and scalable manufacturing operations that support both internal programs and external partnerships. Their advanced manufacturing platform incorporates cutting-edge bioprocessing technologies, quality control systems, and regulatory compliance frameworks essential for pharmaceutical production. REGENXBIO leverages proprietary NAV Technology Platform to engineer novel AAV vectors with enhanced tissue-specific targeting and improved therapeutic efficacy. Their manufacturing operations encompass upstream cell culture processes, downstream purification systems, and analytical testing capabilities that ensure consistent product quality and regulatory standards. The company provides contract development and manufacturing services to pharmaceutical partners while advancing their own clinical pipeline targeting retinal diseases, neurodegenerative conditions, and metabolic disorders. Their integrated approach combines research expertise with robust manufacturing infrastructure to accelerate gene therapy development from laboratory to clinical application. With dedicated facilities featuring controlled environments, automated systems, and comprehensive quality assurance protocols, REGENXBIO delivers reliable manufacturing solutions that meet stringent pharmaceutical industry requirements while supporting the advancement of transformative gene therapies for patients with serious medical conditions.

Specialties

Gene therapy manufacturingAAV vector productionNAV Technology PlatformSuspension cell cultureVector purificationClinical-scale manufacturingCommercial-scale production

Manufacturing Capabilities

Processes

NAVXpress™ platform suspension cell cultureGMP manufacturing up to 2,000L scale

Location

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Rockville, MD •••••